Adriano Lazzarin

Agnes Balogh

Eric Vandeloise

Ghislaine Leleu

Giampiero Carosi

Gilles Pialoux

J Sanz-Moreno

Jean-François Delfraissy

Santiago Moreno

V Pokrovsky

English

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BioMed CentralJournal of the International AIDS SocietyssOpen AcceOral presentationO415 Efficacy and safety of 48-week maintenance with QD ATV vs ATV/r (both + 2NRTIs) in patients with VL <50 c/mL after induction with ATV/r + 2NRTIs: study AI424136JF Delfraissy1, S Moreno*2, J Sanz-Moreno3, G Carosi4, V Pokrovsky5, A Lazzarin6, G Pialoux7, A Balogh8, E Vandeloise8 and G Leleu9Address: 1CHU Bicêtre, Paris, France, 2Dept of Infectious Diseases, Hospital Ramon y Cajal, Univ de Alcalá, Madrid, Spain, 3Hospital Univ. Principe De Asturias, Madrid, Spain, 4Spedali Civili, Brescia, Italy, 5Central Research Institute of Epidemiology, Moscow, Russian Federation, 6Ospedale San Raffaele, Milan, Italy, 7Hopital Tenon, Paris, France, 8Bristol-Myers Squibb, Braine-l'Alleud, Belgium and 9Bristol-Myers Squibb, Rueil Malamaison, France* Corresponding author    Purpose of the studyOnce-daily (QD) atazanavir/ritonavir (ATV/r) + 2NRTIshas proven efficacy with favourable lipid and GI profilesin treatment-experienced and -naive HIV patients (pts).Data are needed on effective simplified treatment strate-gies.MethodsAI424136 (INDUMA) is a randomised, open-label, mult-icentre study to assess non-inferiority (15% margin) of48-week maintenance phase (MP) with ATV 400 mg QDvs. ATV/r 300/100 mg QD (1:1), both + 2NRTIs (excl.TDF), in patients with confirmed HIV-1 RNA <50 c/mL-after a 26–30 week induction phase (IP) with ATV/r +2NRTIs in treatment-naive pts. Primary end-point wasproportion of pts with HIV-RNA <50 c/mL through week48 of MP. Secondary end-points included, percent withHIV RNA <400 c/mL, CD4 cell count change, and safety ofMP.Summary of results252 pts entered IP (median CD4 245 cells/mm3; medianHIV-RNA 4.95 log10 c/mL), during which 30 pts discon-tinued (nine for AEs). At the end of IP (EoI), 50 were notsuppressed and were continued on ATV/r regimen (notdescribed here), and 172 were randomised to MP. Demo-graphics and EoI subject characteristics for MP were well-balanced: median CD4 390 cells/mm3; half of pts were on3TC+ABC. Through week 48 of MP the ATV arm demon-strated similar (non-inferior) efficacy compared to theATV/r arm. (Table 1.)During MP, mean change in CD4 cell count at week 48was +92 (SE = 18.1) cells/mm3 for ATV/r and +100 (SE =14.7) cells/mm3 for ATV; discontinuations prior to week48 were: ATV/r 14%; ATV 8%. Seven pts on ATV/r and 11on ATV experienced virological rebound, none had emer-gence of PI resistance. AEs led to discontinuation in 5%and 1% of pts on ATV/r & ATV, respectively. Lab grade 3–4total bilirubin was reported in 47% and 14% on ATV/r &ATV, respectively. Mean percent triglyceride change fromEoI to week 48 of MP was +9.8 vs. -27.0 for ATV/r & ATV,respectively. The percent of pts who shifted into higherNCEP categories from EoI to week 48 of MP was higher inATV/r than ATV for total cholesterol (23 vs. 10) and trig-lycerides (20 vs. 3).ConclusionThese results are consistent with the proven efficacy of ata-zanavir in naive pts and suggest that for those pts whohave achieved undetectability under ATV/r, switching tofrom Ninth International Congress on Drug Therapy in HIV InfectionGlasgow, UK. 9–13 November 2008Published: 10 November 2008Journal of the International AIDS Society 2008, 11(Suppl 1):O42 doi:10.1186/1758-2652-11-S1-O42<supplement> <title> <p>Abstracts of the Ninth International Congress on Drug Therapy in HIV Infection</p> </title> <note>Meeting abstracts – A single PDF containing all abstracts in this Supplement is available <a href="http://www.biomedcentral.com/content/files/pdf/1758-2652-11-S1-full.pdf">here</a>.</note> <url>http://www.biomedcentral.com/content/pdf/1758-2652-11-S1-info.pdf</url> </supplement>This abstract is available from: http://www.jiasociety.org/content/11/S1/O42© 2008 Delfraissy et al; licensee BioMed Central Ltd. Page 1 of 2(page number not for citation purposes)Journal of the International AIDS Society 2008, 11(Suppl 1):O42 http://www.jiasociety.org/content/11/S1/O42Publish with BioMed Central   and  every scientist can read your work free of charge"BioMed Central will be the most significant development for disseminating the results of biomedical research in our lifetime."Sir Paul Nurse, Cancer Research UKYour research papers will be:available free of charge to the entire biomedical communitypeer reviewed and published immediately upon acceptancecited in PubMed and archived on PubMed Central yours — you keep the copyrightSubmit your manuscript here:http://www.biomedcentral.com/info/publishing_adv.aspBioMedcentralunboosted ATV may be an option that results in simplifi-cation of treatment regimen.Table 1: Proportion of pts with HIV RNA <50/400 c/mL through Wk 48 of MP (ITT)ATV/r (N = 85) ATV (N = 87) Difference Estimate (95%CI) (ATV – ATV/r)% <50 c/mL 75 78 2.9 (69.8, 15.5)% <400 c/mL 81 86Page 2 of 2(page number not for citation purposes)

O415 Efficacy and safety of 48-week maintenance with QD ATV vs ATV/r (both + 2NRTIs) in patients with VL <50 c/mL after induction with ATV/r + 2NRTIs: study AI424136

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O415 Efficacy and safety of 48-week maintenance with QD ATV vs ATV/r (both + 2NRTIs) in patients with VL <50 c/mL after induction with ATV/r + 2NRTIs: study AI424136

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